Finasteride 5mg Film Coated Tablets
Out of date information, search another1. What Proscar is and what it is used for
3. How to take Proscar
PACKAGE LEAFLET: INFORMATION FOR THE USER PROSCAR® 5 MG FILM-COATED TABLETS
(finasteride)
This product will be referred to as Proscar throughout this leaflet.
This medicine is for use in men only
Read all of this leaflet carefully before you start to take this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Proscar is and what it is used for
2. Before you take Proscar
3. How to take Proscar
4. Possible side effects
5. How to store Proscar
6. Further information
Proscar contains a medicine called finasteride. This belongs to a group of medicines called '5-alpha reductase inhibitors'.
Proscar shrinks the prostate gland in men when it is swollen. The prostate gland is found underneath the bladder (but only in men). It produces the fluid found in semen. A swollen prostate gland can lead to a condition called 'benign prostatic hyperplasia' or BPH.
What is BPH?
If you have BPH it means that your prostate gland is swollen. It can press on the tube that urine passes through, on its way out of your body.
This can lead to problems such as:
• feeling like you need to pass urine more often, especially at night
• feeling that you must pass urine right away
• finding it difficult to start passing urine
• when you pass urine the flow of urine is weak
• when you pass urine the flow stops and starts
• feeling that you cannot empty your bladder completely.
In some men, BPH can lead to more serious problems, such as:
• urinary tract infections
• a sudden inability to pass urine
• the need for surgery.
What else should you know about BPH?
• BPH is not cancer and does not lead to cancer, but the two conditions can be present at the same time.
• Before you start Proscar, your doctor will do some simple tests to check whether you have prostate cancer.
Talk to your doctor if you have any questions about this.
2. Before you take Proscar Do not take Proscar if:
• you are a woman (because this medicine is for men)
• you are allergic (hypersensitive) to finasteride or any of the other ingredients (listed in Section 6).
Do not take Proscar if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.
Take special care with Proscar
Check with your doctor or pharmacist before taking your
medicine if:
• your partner is pregnant or planning to become pregnant. You should use a condom or other barrier method of contraception when taking Proscar. This is because your semen could contain a tiny amount of the drug and may affect the normal development of the baby's sex organs.
• you are going to have a blood test called PSA. This is because Proscar can affect the results of this test.
If you are not sure, talk to your doctor or pharmacist before taking Proscar.
Taking other medicines
Proscar does not usually affect other medicines. Always tell your doctor about all medicines you are taking or planning to take, including any obtained without a prescription.
Taking Proscar with food and drink
Proscar can be taken with or without food.
Pregnancy and breast feeding
• Proscar should not be taken by women.
• Do not touch crushed or broken Proscar tablets if you are a woman who is pregnant or planning to become pregnant (whole tablets are coated to stop contact with the medicine during normal use). This is because this medicine may affect the normal development of the baby's sex organs.
• If a woman who is pregnant comes into contact with crushed or broken Proscar tablets, speak to your doctor.
Driving and using machines
Proscar is not likely to affect you being able to drive, use tools
or machines.
Important information about some of the ingredients of Proscar
Proscar contains lactose, which is a type of sugar. If you have ever been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
You should take your tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• The usual dose is one tablet each day.
• Take this medicine by mouth.
• Your doctor may prescribe Proscar along with another medicine (called doxazosin) to help control your BPH.
If you take more Proscar than you should
If you take too many tablets by mistake, contact your doctor immediately.
If you forget to take Proscar
• If you forget to take a tablet, skip the missed dose.
• Take the next dose as usual.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Proscar
Your condition may show an early improvement after taking Proscar. However, it may take at least six months for the full effect to develop. It is important to keep taking Proscar for as long as your doctor tells you, even if you do not feel any benefit straight away.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Proscar should not be used in children.
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6. Further information
Like all medicines, Proscar can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Allergic reactions
If you have an allergic reaction, stop taking it and see your doctor straight away. The signs may include:
• Skin rashes, itching, or lumps under your skin (hives)
• Swelling of your lips and face.
Other side effects may include:
• You may be unable to have an erection (impotence)
• You may have less desire to have sex
• You may have problems with ejaculation, for example a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function.
These side effects above may disappear after a while if you continue taking Proscar. If not, they usually resolve after stopping Proscar. Other side effects reported in some men are:
• Breast swelling or tenderness
• Palpitations (feeling your heartbeat)
• Changes in the way your liver is working, which can be shown by a blood test
• Pain in your testicles
• An inability to have an erection which may continue after stopping the medication
• Male infertility and/or poor quality of semen. Improvement in the quality of the semen has been reported after stopping medication
• Depression
• Decrease in sex drive that may continue after stopping the medication
• Problems with ejaculation that may continue after stopping the medication
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement or nipple discharge as these may be signs of a serious condition, such as breast cancer.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. It will help if you make a note of what happened, when it started and how long it lasted.
Do not use Proscar after the expiry date which is stated on the carton after the letters EXP. The expiry date refers to the last day of that month.
If your Proscar tablets become discolored or show any signs of deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Proscar contains
• The active ingredient in Proscar tablets is finasteride.
Each film-coated tablet contains 5mg finasteride.
• The other ingredients in Proscar tablets are: lactose monohydrate, pregelatinised maize starch, sodium starch glycollate, microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, docusate sodium, talc, magnesium stearate, yellow iron oxide (E172), titanium dioxide (E171) and indigo carmine aluminium lake (E132).
What Proscar looks like and the content of the pack
Proscar is available as blue, apple-shaped, film-coated tablets engraved 'PROSCAR' on one side and 'MSD 72' on the other side.
Proscar tablets are supplied in calendar blister packs of 98 tablets.
Manufacturer and Product Licence holder
Proscar tablets are manufactured by Merck Sharp & Dohme Limited, Cramlington, England. Procured from within the EU and repackaged by the Product Licence holder: G-Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1375
PROSCAR® 5 mg Film-coated Tablets 1st October 2013
'Proscar' is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.
What else should you know about Proscar?
Proscar (finasteride) is not licensed to treat prostate cancer.
Information collected for a clinical trial in men taking finasteride
for 7 years showed:
• The number of men who developed prostate cancer was lower in men taking finasteride compared with those taking nothing.
• The number of men who had a high score in a tumour grading system was higher in some of those taking finasteride compared to those taking nothing.
• The effect of long-term use of finasteride on tumours of this kind is not known.
If you would like further information about the tumour grading system or this trial, please talk to your doctor.
Keep your tablets out of the sight and reach of children.
Do not store above 25°C. Store in a dry place. Protect from light. Store in the original package.
1. What Finasteride is and what it is used for
2. Before you take Finasteride
3. How to take Finasteride
PACKAGE LEAFLET: INFORMATION FOR THE USER FINASTERIDE 5 MG FILM-COATED TABLETS
(finasteride)
This product will be referred to as Finasteride throughout this leaflet.
This medicine is for use in men only
Read all of this leaflet carefully before you start to take this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Finasteride is and what it is used for
2. Before you take Finasteride
3. How to take Finasteride
4. Possible side effects
5. How to store Finasteride
6. Further information
Finasteride contains a medicine called finasteride. This belongs to a group of medicines called '5-alpha reductase inhibitors'.
Finasteride shrinks the prostate gland in men when it is swollen. The prostate gland is found underneath the bladder (but only in men). It produces the fluid found in semen. A swollen prostate gland can lead to a condition called 'benign prostatic hyperplasia' or BPH.
What is BPH?
If you have BPH it means that your prostate gland is swollen. It can press on the tube that urine passes through, on its way out of your body.
This can lead to problems such as:
• feeling like you need to pass urine more often, especially at night
• feeling that you must pass urine right away
• finding it difficult to start passing urine
• when you pass urine the flow of urine is weak
• when you pass urine the flow stops and starts
• feeling that you cannot empty your bladder completely.
In some men, BPH can lead to more serious problems, such as:
• urinary tract infections
• a sudden inability to pass urine
• the need for surgery.
What else should you know about BPH?
• BPH is not cancer and does not lead to cancer, but the two conditions can be present at the same time.
• Before you start Finasteride, your doctor will do some simple tests to check whether you have prostate cancer.
Talk to your doctor if you have any questions about this.
Do not take Finasteride if:
• you are a woman (because this medicine is for men)
• you are allergic (hypersensitive) to finasteride or any of the other ingredients (listed in Section 6).
Do not take Finasteride if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.
Take special care with Finasteride
Check with your doctor or pharmacist before taking your medicine if:
• your partner is pregnant or planning to become pregnant. You should use a condom or other barrier method of contraception when taking Finasteride. This is because your semen could contain a tiny amount of the drug and may affect the normal development of the baby's sex organs.
• you are going to have a blood test called PSA. This is because Finasteride can affect the results of this test.
If you are not sure, talk to your doctor or pharmacist before taking Finasteride.
Taking other medicines
Finasteride does not usually affect other medicines. Always tell your doctor about all medicines you are taking or planning to take, including any obtained without a prescription.
Taking Finasteride with food and drink
Finasteride can be taken with or without food.
Pregnancy and breast feeding
• Finasteride should not be taken by women.
• Do not touch crushed or broken Finasteride tablets if you are a woman who is pregnant or planning to become pregnant (whole tablets are coated to stop contact with the medicine during normal use). This is because this medicine may affect the normal development of the baby's sex organs.
• If a woman who is pregnant comes into contact with crushed or broken Finasteride tablets, speak to your doctor.
Driving and using machines
Finasteride is not likely to affect you being able to drive, use
tools or machines.
Important information about some of the ingredients of Finasteride
Finasteride contains lactose, which is a type of sugar. If you have ever been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
You should take your tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• The usual dose is one tablet each day.
• Take this medicine by mouth.
• Your doctor may prescribe Finasteride along with another medicine (called doxazosin) to help control your BPH.
If you take more Finasteride than you should
If you take too many tablets by mistake, contact your doctor immediately.
If you forget to take Finasteride
• If you forget to take a tablet, skip the missed dose.
• Take the next dose as usual.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Finasteride
Your condition may show an early improvement after taking Finasteride. However, it may take at least six months for the full effect to develop. It is important to keep taking Finasteride for as long as your doctor tells you, even if you do not feel any benefit straight away.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Finasteride should not be used in children.
6. Further information
Like all medicines, Proscar can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Allergic reactions
If you have an allergic reaction, stop taking it and see your doctor straight away. The signs may include:
• Skin rashes, itching, or lumps under your skin (hives)
• Swelling of your lips and face.
Other side effects may include:
• You may be unable to have an erection (impotence)
• You may have less desire to have sex
• You may have problems with ejaculation, for example a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function.
These side effects above may disappear after a while if you continue taking Proscar. If not, they usually resolve after stopping Proscar. Other side effects reported in some men are:
• Breast swelling or tenderness
• Palpitations (feeling your heartbeat)
• Changes in the way your liver is working, which can be shown by a blood test
• Pain in your testicles
• An inability to have an erection which may continue after stopping the medication
• Male infertility and/or poor quality of semen. Improvement in the quality of the semen has been reported after stopping medication
• Depression
• Decrease in sex drive that may continue after stopping the medication
• Problems with ejaculation that may continue after stopping the medication
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement or nipple discharge as these may be signs of a serious condition, such as breast cancer.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. It will help if you make a note of what happened, when it started and how long it lasted.
What else should you know about Proscar?
Proscar (finasteride) is not licensed to treat prostate cancer. Information collected for a clinical trial in men taking finasteride for 7 years showed:
• The number of men who developed prostate cancer was lower in men taking finasteride compared with those taking nothing.
• The number of men who had a high score in a tumour grading system was higher in some of those taking finasteride compared to those taking nothing.
• The effect of long-term use of finasteride on tumours of this kind is not known.
If you would like further information about the tumour grading system or this trial, please talk to your doctor.
Do not use Finasteride after the expiry date which is stated on the carton after the letters EXP. The expiry date refers to the last day of that month.
If your Finasteride tablets become discolored or show any signs of deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Finasteride contains
• The active ingredient in Finasteride tablets is finasteride. Each film-coated tablet contains 5mg finasteride.
• The other ingredients in Finasteride tablets are: lactose monohydrate, pregelatinised maize starch, sodium starch glycollate, microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, docusate sodium, talc, magnesium stearate, yellow iron oxide (E172), titanium dioxide (E171) and indigo carmine aluminium lake (E132).
What Finasteride looks like and the content of the pack
Finasteride is available as blue, apple-shaped, film-coated tablets engraved 'FINASTERIDE' on one side and 'MSD 72' on the other side.
Finasteride tablets are supplied in calendar blister packs of 98 tablets.
Manufacturer and Product Licence holder
Finasteride tablets are manufactured by Merck Sharp & Dohme Limited, Cramlington, England. Procured from within the EU and repackaged by the Product Licence holder: G-Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1375
FINASTERIDE® 5 mg Film-coated Tablets 1st October 2013
'Finasteride' is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.
Keep your tablets out of the sight and reach of children.
Do not store above 25°C. Store in a dry place. Protect from light. Store in the original package.
If you have been given a calendar pack, do not remove the
tablets from the blister until you are ready to take the medicine.